Device Classification Name |
Single (Specified) Analyte Controls (Assayed And Unassayed)
|
510(k) Number |
K760885 |
Device Name |
KETOTROL-E |
Applicant |
SIGMA CHEMICAL CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
SIGMA CHEMICAL CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 10/22/1976 |
Decision Date | 11/05/1976 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|